A Study of Evacetrapib in Healthy Japanese Participants

NCT ID: NCT02226653

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-04-30

Brief Summary

The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Evacetrapib (reference)

Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally

Evacetrapib (test)

Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally

Interventions

Evacetrapib

Administered orally

Intervention Type: DRUG

Other Intervention Names

LY2484595

Eligibility Criteria

Inclusion Criteria

• Overtly healthy Japanese, as determined by medical history and physical examination
• Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have an abnormal supine blood pressure as determined by the investigator
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Are women who are pregnant or lactating
• Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
• Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
• Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Fukuoka, , Japan

Countries

Japan

Other Identifiers

14627

Identifier Type: -

Identifier Source: org_study_id

I1V-JE-EIAY

Identifier Type: OTHER

Identifier Source: secondary_id